A study looking for gene changes in prostate cancer that has spread and hormone treatment is no longer working (MAESTRO)

Cancer type:

Prostate cancer

Status:

Open

Phase:

Other

This study is looking for gene changes in the DNA of prostate cancer cells.

It is open to men with prostate cancer that has spread despite having hormone therapy or surgery to remove the testicles (castration resistant metastatic prostate cancer).

More about this trial

DNA Open a glossary item is inside each cell. It contains the genetic information that tells the body’s cells how to behave. Permanent changes to the genes that make up DNA are mutations .

The type of prostate cancer you have depends on what mutations there are in your cancer cells. There are many possible mutations. New mutations often happen after treatment or when the cancer spreads.

In this study you have a sample of cancer tissue (biopsy Open a glossary item ) taken to find out what mutations are in the cells of your cancer.

The researchers will look for mutations in the tissue samples that might mean you can have treatment with targeted therapies Open a glossary item .

If they find a mutation that a targeted therapy could treat, you may be able to join a clinical trial looking at that targeted therapy.

The main aim of this trial is to find out if there are mutations in advanced prostate cancer that can be treated with targeted therapies.

When cancer cells die they release bits of DNA into the bloodstream (Circulating tumour DNA Open a glossary item ). The researchers want to find out if the gene changes they find by taking a biopsy are the same as those in the bits of DNA in the blood stream. If they are they might be able to use this information instead of taking a biopsy to work out what treatment people need.

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

Who can take part

You may be able to join this study if all of the following apply. You:

have prostate cancer that has spread despite having hormone therapy or surgery to remove your testicles
have adenocarcinoma prostate cancer
have a scan that shows where the cancer has spread
have available tissue samples from when you were diagnosed
are willing and able to have a fresh tissue sample (biopsy) done
have satisfactory blood test results
can look after yourself but might not be able to work (performance status 0, 1 or 2)
are at least 18 years old

Who can’t take part

You cannot join this study if any of these apply. You:

are not able to have a biopsy taken because you have problems with bleeding
have any other medical condition or mental health problem that your doctor or the study team think could affect you taking part

Trial design

The study team need about 600 people to take part.

The team take a sample of prostate cancer tissue with a needle (needle biopsy). They might use an ultrasound scan Open a glossary item or a CT scan to guide where to take the sample from.

You might not need to have this sample done if you had one done less than 6 months ago and the study team can use it.

The team may also take a sample of bone marrow Open a glossary item .

You give blood and spit (saliva) samples.

Researchers test these samples to look for gene changes (mutations) that might be targets for future treatments.

When they know the results of the tests they will tell your doctor. It is up to you to choose whether you want to know the results or not.

If you choose to know the results your doctor will discuss them with you. The results might show that you could pass these gene changes on to your children (inherited Open a glossary item ). If this is so your doctor will recommend you see a specialist (cancer geneticist) who can tell you more about it.